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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adhesive, Bracket And Tooth Conditioner, Resin
510(k) Number K921385
Device Name IMPROVED SEQUENCE LIGHT CURE ADHESIVE
Applicant
Ormco Corp.
1332 S. Lone Hill Ave.
Glendora,  CA  91740
Applicant Contact FRANCES ZEE
Correspondent
Ormco Corp.
1332 S. Lone Hill Ave.
Glendora,  CA  91740
Correspondent Contact FRANCES ZEE
Regulation Number872.3750
Classification Product Code
DYH  
Date Received03/23/1992
Decision Date 04/21/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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